Class II — Riverpoint Medical, LLC
| Recalling firm | Riverpoint Medical LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence. |
| Product | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 |
| Quantity | 3060 units |
| Distribution | US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain. |
| Initiated | 2020-12-09 |
| Classified | 2021-02-03 |
| Terminated | 2023-04-21 |
| Recall number | Z-0949-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Riverpoint Medical, LLC (Z-0949-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87036/
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